AsthmaPhase 2NCT01573767

Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

A Phase 2 study testing Fluticasone propionate 100mcg and Vilanterol in people with Asthma, run by GlaxoSmithKline at 120 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 5 to 11 years
Conditions the study is for: Asthma
What is being tested?: Fluticasone propionate 100mcg and Vilanterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 463 participants
Where: 120 sitesin 14 countries
Study dates: Apr 2012to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Written informed consent from at least one parent/ legal guardian to take part in the study.:
Diagnosis of asthma
pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

Who cannot join

history of life-threatening asthma
history of asthma exacerbation for asthma within 6 months prior to screening.
Culture-documented or suspected bacterial or viral infection
significant abnormality or medical condition
Present use of any tobacco products

Trial locations and contacts

120 sites in 14 countries.

Country

City, postcode or hospital

120 sites in 14 countries

United States34 sites

GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dayton, Ohio, 45414
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Lenexa, Kansas, 66215
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Nicholasville, Kentucky, 40356
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Omaha, Nebraska, 68107
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Shiloh, Illinois, 62269
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Spring, Texas, 77379
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
White Marsh, Maryland, 21162

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Germany17 sites

GSK Investigational Site
Baunatal-Grossenritte, Hesse, 34225
GSK Investigational Site
Berlin, State of Berlin, 10785
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22415
GSK Investigational Site
Hamm, North Rhine-Westphalia, 59063
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Rosenheim, Bavaria, 83026
GSK Investigational Site
Wesel, North Rhine-Westphalia, 46483
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302

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Argentina14 sites

GSK Investigational Site
Berazategui, 1886
GSK Investigational Site
Buenos Aires, C1121ABE
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, C1431FWO
GSK Investigational Site
La Plata, Buenos Aires, 1900
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600
GSK Investigational Site
Mendoza, Mendoza Province, M5500CCG
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ
GSK Investigational Site
Rosario, Santa Fe Province, S2000DBS
GSK Investigational Site
Rosario, Santa Fe Province, S2000JKR
GSK Investigational Site
Rosario, S2000BRH
GSK Investigational Site
Salta, Salta Province, A4400ERH
GSK Investigational Site
San Juan Bautista, Buenos Aires, 1888
GSK Investigational Site
San Miguel de Tucumán, 4000

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Japan12 sites

GSK Investigational Site
Chiba, 260-0001
GSK Investigational Site
Chiba, 273-0035
GSK Investigational Site
Fukuoka, 811-1394
GSK Investigational Site
Hiroshima, 720-8520
GSK Investigational Site
Hokkaido, 006-0831
GSK Investigational Site
Hokkaido, 064-0821
GSK Investigational Site
Hyōgo, 653-0021
GSK Investigational Site
Kagawa, 762-0031
GSK Investigational Site
Tokyo, 154-0017
GSK Investigational Site
Tokyo, 157-0066
GSK Investigational Site
Tokyo, 158-0097
GSK Investigational Site
Wakayama, 646-8558

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Poland10 sites

GSK Investigational Site
Bieńkówka, 34-212
GSK Investigational Site
Bydgoszcz, 85-096
GSK Investigational Site
Krakow, 31-159
GSK Investigational Site
Lublin, 20-093
GSK Investigational Site
Oleśnica, 56-400
GSK Investigational Site
Ostrów Wielkopolski, 63-400
GSK Investigational Site
Siemianowice Śląskie, 41-103
GSK Investigational Site
Wroclaw, 50-445
GSK Investigational Site
Wroclaw, 51-511
GSK Investigational Site
Zawadzkie, 47-120

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Ukraine5 sites

GSK Investigational Site
Kharkiv, 61093
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Kyiv, 04050
GSK Investigational Site
Zaporizhia, 69063
GSK Investigational Site
Zaporizhia, 69076

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Chile4 sites

GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257
GSK Investigational Site
Santiago, Región Metro de Santiago, 7520349
GSK Investigational Site
Santiago, 8380453
GSK Investigational Site
Viña del Mar, 2520594

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Georgia4 sites

GSK Investigational Site
Tbilisi, 0119
GSK Investigational Site
Tbilisi, 0159
GSK Investigational Site
Tbilisi, 0160
GSK Investigational Site
Tbilisi, 0186

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Mexico4 sites

GSK Investigational Site
Mexico City, 04530
GSK Investigational Site
Puebla, Pue, Puebla, 72000
GSK Investigational Site
Villahermosa, Tabasco, 86100
GSK Investigational Site
Zapopan, Jalisco, 45040

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Peru4 sites

GSK Investigational Site
Lima, Lima Province, Lima 1
GSK Investigational Site
Lima, Lima Province, Lima 27
GSK Investigational Site
San Miguel, Lima region, Lima 32
GSK Investigational Site
Santiago de Surco, Lima region, Lima 33

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Philippines4 sites

GSK Investigational Site
Cebu City, 6000
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Quezon City, 1100
GSK Investigational Site
Quezon City, 1113

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South Africa4 sites

GSK Investigational Site
CapeTown, 7764
GSK Investigational Site
Meyerspark, Gauteng, 0184
GSK Investigational Site
Middelburg, 1501
GSK Investigational Site
Panorama, 7500

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Slovakia3 sites

GSK Investigational Site
Bratislava, 826 05
GSK Investigational Site
Martin, 036 59
GSK Investigational Site
Vysoké Tatry, 059 81

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Puerto Rico1 site

GSK Investigational Site
Hato Rey, Puerto Rico, 00917

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About this study

Official title: A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy

This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.

Conditions: Asthma
Being tested: Fluticasone propionate 100mcg, Placebo, Vilanterol
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone propionate 100mcgDrug
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
PlaceboDrug
Placebo inhalation powder during treatment period
VilanterolDrug
subjects will recieve 4 weeks via NDPI during treament period

Study groups in NCT01573767
Study group	Role	What they receive
Arm 1	Active comparator	Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler Receives: Drug: Fluticasone propionate 100mcg; Drug: Vilanterol
Arm 2	Active comparator	Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler Receives: Drug: Fluticasone propionate 100mcg; Drug: Vilanterol
Arm 3	Active comparator	Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler Receives: Drug: Fluticasone propionate 100mcg; Drug: Vilanterol
Arm 4	Placebo comparator	Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler Receives: Drug: Fluticasone propionate 100mcg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.
Measured: Baseline; Week 1 up to Week 4

Secondary outcomes (6)

Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Measured: Baseline; Week 4
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Measured: Baseline; Week 1 up to Week 4
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Measured: Baseline; Week 1 up to Week 4
Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Measured: Baseline; Week 4
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Measured: Baseline; Week 4
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Measured: Baseline; Week 1 up to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Apr 2014

First posted10 Apr 2012 (estimated)
Study startApr 2012
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 463 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01573767
Sponsor's protocol ID: 106853
Status last verified: Nov 2016
First submitted: 8 Mar 2012
Last updated: 9 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Oliver AJ, Covar RA, Goldfrad CH, Klein RM, Pedersen SE, Sorkness CA, Tomkins SA, Villaran C, Grigg J. Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy. Respir Res. 2016 Apr 5;17:37. doi: 10.1186/s12931-016-0353-4.
PubMed 27044326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
ClinicalTrials.gov ID: NCT01573767
Acronym / sponsor ID: 106853
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 463 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 10 Apr 2012 (estimated)
Results: Posted 3 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Arm 1	Active comparator	Drug: Fluticasone propionate 100mcg, Drug: VilanterolVilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Arm 2	Active comparator	Drug: Fluticasone propionate 100mcg, Drug: VilanterolVilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Arm 3	Active comparator	Drug: Fluticasone propionate 100mcg, Drug: VilanterolVilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Arm 4	Placebo comparator	Drug: Fluticasone propionate 100mcg, Drug: PlaceboPlacebo inhalation powder inhaled once daily in the PM via the new powder inhaler

Who may qualify

Ages: 5 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Written informed consent from at least one parent/ legal guardian to take part in the study.:
Diagnosis of asthma
pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

Key exclusion criteria (5 listed)

history of life-threatening asthma
history of asthma exacerbation for asthma within 6 months prior to screening.
Culture-documented or suspected bacterial or viral infection
significant abnormality or medical condition
Present use of any tobacco products

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone propionate 100mcgall subjects recieve open-label Flovent twice daily duirng the run in and treatment period	Drug	Arm 1, Arm 2, Arm 3, Arm 4
PlaceboPlacebo inhalation powder during treatment period	Drug	Arm 4
Vilanterolsubjects will recieve 4 weeks via NDPI during treament period	Drug	Arm 1, Arm 2, Arm 3

Primary outcome

Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period
Time frame: Baseline; Week 1 up to Week 4
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.

6 secondary outcomes

Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver
Time frame: Baseline; Week 4
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period
Time frame: Baseline; Week 1 up to Week 4
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period
Time frame: Baseline; Week 1 up to Week 4
Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)
Time frame: Baseline; Week 4
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)
Time frame: Baseline; Week 4
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period
Time frame: Baseline; Week 1 up to Week 4

Results and safety

Results posted to the registry on 3 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	115	93
VI 6.25 µg OD	114	93
VI 12.5 µg OD	113	99
VI 25 µg OD	114	90

Primary outcome: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period

Time frame: Baseline; Week 1 up to Week 4. Least squares mean (Standard Error). Unit: Liters per minute (L/min)

Measure	Placebo n = 113	VI 6.25 µg OD n = 113	VI 12.5 µg OD n = 112	VI 25 µg OD n = 110
Value	215.9 (2.53)	221.4 (2.53)	222.4 (2.54)	220.3 (2.56)

Placebo vs VI 25 µg OD: Mean Difference (Final Values): 4.4 (95% CI -2.7 to 11.4), p = 0.227, ANCOVA
Placebo vs VI 12.5 µg OD: Mean Difference (Final Values): 6.4 (95% CI -0.6 to 13.5), p = 0.073, ANCOVA
Placebo vs VI 6.25 µg OD: Mean Difference (Final Values): 5.5 (95% CI -1.6 to 12.5), p = 0.127, ANCOVA

Population analysed: ITT Population: participants randomized to treatment who received \>=1 dose of study medication

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 115 (0%)	10 of 115 (8.7%)	Not reported
VI 6.25 OD	0 of 114 (0%)	17 of 114 (14.9%)	Not reported
VI 12.5 OD	0 of 113 (0%)	12 of 113 (10.6%)	Not reported
VI 25 OD	1 of 114 (0.9%)	11 of 114 (9.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27044326Oliver AJ, Covar RA, Goldfrad CH, Klein RM, Pedersen SE, Sorkness CA, Tomkins SA, Villaran C, Grigg J. Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy. Respir Res. 2016 Apr 5;17:37. doi: 10.1186/s12931-016-0353-4.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

120 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluticasone propionate 100mcg and Vilanterol in people with Asthma, run by GlaxoSmithKline at 120 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Germany, Argentina, Japan, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period (time frame: Baseline; Week 1 up to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01573767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.